MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S2 RM

Model Number	02.18.TF2.RM
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 april 2021: lot 170790: (b)(4) items manufactured and released on 27-jun-2017.Expiration date: 2022-06-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medacta medical affairs director: few months after primary uka the medial tibial bone gives way completely and revision is required.We do not know if the bone failure was due to the consequences of the surgical preparation or to low mechanical quality of the bone.No trauma is reported.There is no reason to think that the failure is due to a defective implant.Corrected data: on the 29 april 2021 this mdr was sent to the fda test webtrader (https://esgtest.Fda.Gov) for error.Today 9 september 2021 we recognized the error and sent the mdr to fda production webtrader (https://esg.Fda.Gov).
Event or Problem Description
3 months after the primary surgery a revision was performed due to the sinking of the medial tibial plateau.The patient reported that she had not fallen.The surgeon revised all implants.

• Brand Name: MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S2 RM
• Common Device Name: KNEE TIBIAL TRAY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12438439
• Report Number: 3005180920-2021-00341
• Device Sequence Number: 11707076
• Product Code: HSX
• UDI-Device Identifier: 07630030896729
• UDI-Public: 07630030896729
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/07/2022
• Device Model Number: 02.18.TF2.RM
• Device Catalogue Number: 02.18.TF2.RM
• Device Lot Number: 170790
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR